Contract Opportunity - Medical Device Auditors
SGSNorth AmericaContractEngineering
Remotely
sterilizationmdrmdsapiso 13485mddeo
Job Description
📋 Description
- Contract role requiring travel for audits in the United States, Canada and Mexico.
- Perform third-party audits per SGS procedures and ISO 13485, MDSAP, MDD, MDR.
- Assess evidence to determine certification recommendations and conformity.
- Conduct audits for medical device quality systems and technical information to regulatory
- Participate in witness audits and maintain audit credentials.
- Adhere to internal standards, policies, and procedures.
🎯 Requirements
- Bachelor’s degree in Engineering, Bioscience, Biomedical, or related field.
- Minimum 4 years of experience with medical devices under ISO 13485, MDSAP, MDD and/or MDR compliant
- Preferred: Auditor credentials for ISO 13485, MDSAP, MDD or MDR.
- Experience with non-active cardiovascular implants, non-active ophthalmologic devices
- Strong English communication and organizational skills; ability to multitask and manage multiple
🎁 Benefits
- Travel up to 80% of the time (car and air travel).
- Potential travel to Canada and Mexico for audits.
- Competitive contract opportunities with SGS.